In development
Dazucorilant
Also known as CORT113176
Bottom line
Did not slow loss of function in its only trial. Fewer people died on the higher dose, but this is a secondary, after-the-fact finding, and many stopped the drug due to stomach pain. A Phase 3 trial to test survival has not started.
Dazucorilant is a daily pill that blocks some effects of the stress hormone cortisol. In the 249-person DAZALS trial it did not slow the loss of daily function, which was the main goal, but fewer people died on the higher dose, a secondary and exploratory finding that needs confirming. Corcept plans a confirmatory Phase 3 trial, which it now expects to start in 2027.
Information checked 5 Nov 2026
Evidence: Hints only
Studies: 2 mixed
Controlled trials missed their main goal. Some measures or subgroups looked better, which needs confirming.
No effect on function; fewer deaths (exploratory)
Deaths by April 2026: 22 of 83 on 300 mg vs 32 of 82 on placebo; function no different at 24 weeks
DAZALS 1- and 2-year survival analysesMixed
The 84-87% lower risk of death compares 83 people on 300 mg with only 18 placebo patients who never switched to the drug. Counting everyone as first assigned, deaths were 22 of 83 on 300 mg and 32 of 82 on placebo.
DAZALSMixed
Missed its main goal: over 24 weeks, function declined about as much on either dose (about 7 to 7.5 points) as on placebo (6.8). Survival, a secondary goal, was better on 300 mg (0 vs 5 deaths), but many people on the drug stopped early because of stomach pain.
At a glance
CompanyCorcept TherapeuticsExplanation and sources
Corcept is a profitable company in Redwood City, California, that sells cortisol-blocking medicines for Cushing's syndrome (Korlym) and ovarian cancer (Lifyorli). It reported $340.5 million in revenue for the third quarter of 2026 and $662.3 million in cash and investments, so money is not the main constraint. ALS is one of several programmes; most of its effort goes to hormone disorders and cancer.
Sources
- Corcept Therapeutics Announces Third Quarter Financial Results and Provides Corporate Update (2026)Corcept Therapeutics · 3 Nov 2026 · Company press release
- Corcept Therapeutics Form 10-Q for the quarter ended September 30, 2026U.S. Securities and Exchange Commission · Regulator
How it worksBlocks some effects of the stress hormone cortisolSelective glucocorticoid receptor modulator (cortisol modulator)Explanation and sources
Cortisol is a stress hormone. Dazucorilant attaches to the glucocorticoid receptor, the docking site cortisol uses, and blocks or tunes down its signal. The idea is that too much cortisol signalling may add to nerve damage and inflammation in ALS. How this would protect motor neurons is not yet proven.
Sources
- Corcept Phase 2 Study of Dazucorilant Demonstrates Two-Year Overall Survival Benefit in Patients with Amyotrophic Lateral SclerosisCorcept Therapeutics · 30 Apr 2026 · Company press release
- 2-Year Overall Survival Results From DAZALS (NEALS 2026 poster)Corcept Therapeutics · 29 Oct 2026 · Conference presentation
StagePhase 2Phase 2 done (missed main goal); Phase 3 planned for 2027Explanation and sources
DAZALS, a placebo-controlled Phase 2 trial of 249 people in Europe, the US and Canada, reported in December 2024 that it missed its main goal. Its open-label extension continues, and a second part of the study is testing whether starting at a low dose and slowly increasing it reduces stomach pain. Corcept has moved the planned Phase 3 start three times: by mid-2026, then later in 2026, then early 2027; in November 2026 it said only "next year". The FDA has granted Fast Track and orphan drug status.
Sources
- Corcept Announces Results From Phase 2 Study of Dazucorilant in Patients With Amyotrophic Lateral Sclerosis (ALS)Corcept Therapeutics · 11 Dec 2024 · Company press release
- DAZALS trial of dazucorilant in ALS (NCT05407324)ClinicalTrials.gov · Trial registry
- Corcept Therapeutics Announces Third Quarter Financial Results, Oncology Development Programs and Provides Corporate Update (2025)Corcept Therapeutics · 4 Nov 2025 · Company press release
- Corcept Therapeutics Announces First Quarter Financial Results and Provides Corporate Update (2026)Corcept Therapeutics (via StockTitan) · 30 Apr 2026 · Company press release
- Corcept Therapeutics Announces Second Quarter Financial Results and Provides Corporate Update (2026)Corcept Therapeutics · 29 Jul 2026 · Company press release
- Corcept Therapeutics Announces Third Quarter Financial Results and Provides Corporate Update (2026)Corcept Therapeutics · 3 Nov 2026 · Company press release
Best reported effectNo effect on function; fewer deaths (exploratory)Deaths by April 2026: 22 of 83 on 300 mg vs 32 of 82 on placebo; function no different at 24 weeksExplanation and sources
Over 24 weeks, the drug did not slow the loss of daily function (ALSFRS-R), the main goal: people on either dose lost about 7 to 7.5 points, and people on placebo 6.8. On survival, nobody on 300 mg died in those 24 weeks versus 5 of 82 on placebo. The headline 84% (one year) and 87% (two years) lower risk of death compare the 83 people on 300 mg with only the 18 placebo patients who never switched to the drug, an exploratory comparison that can be biased. Counting everyone as first assigned, deaths by April 2026 were 22 of 83 on 300 mg, 27 of 83 on 150 mg and 32 of 82 on placebo.
Sources
- Corcept Announces Results From Phase 2 Study of Dazucorilant in Patients With Amyotrophic Lateral Sclerosis (ALS)Corcept Therapeutics · 11 Dec 2024 · Company press release
- DAZALS results poster, ENCALS 2025Corcept Therapeutics · 5 Jun 2025 · Conference presentation
- DAZALS: A Phase 2, Randomized, Double Blind, Placebo-Controlled Trial of Dazucorilant in ALS (ENCALS 2025 presentation)Corcept Therapeutics · Conference presentation
- Corcept Phase 2 Study of Dazucorilant Demonstrates Two-Year Overall Survival Benefit in Patients with Amyotrophic Lateral SclerosisCorcept Therapeutics · 30 Apr 2026 · Company press release
- 2-Year Overall Survival Results From DAZALS (NEALS 2026 poster)Corcept Therapeutics · 29 Oct 2026 · Conference presentation
Who it's forAdults with ALSAll ALS · Pill, once dailyExplanation and sources
DAZALS enrolled adults with ALS at 35 sites in 10 countries in Europe and North America. The dose being taken forward is 300 mg, taken as capsules once a day. Stomach pain was the main side effect: BioSpace reports that about 58% of people on 300 mg stopped the drug because of side effects, mostly stomach-related.
Sources
- DAZALS results poster, ENCALS 2025Corcept Therapeutics · 5 Jun 2025 · Conference presentation
- 2-Year Overall Survival Results From DAZALS (NEALS 2026 poster)Corcept Therapeutics · 29 Oct 2026 · Conference presentation
- DAZALS trial of dazucorilant in ALS (NCT05407324)ClinicalTrials.gov · Trial registry
- Corcept ties ALS drug to improved 2-year survival as Phase 3 start date nearsBioSpace · News
What's nextStart of a pivotal Phase 3 trial of the 300 mg doseExpected 2027Explanation and sources
In July 2026 Corcept said the Phase 3 trial would start early in 2027; in its November 2026 update it said only that the trial is planned to begin next year. The goal is to confirm the survival benefit. Design details, including sites, have not been published yet.
Sources
- Corcept Therapeutics Announces Second Quarter Financial Results and Provides Corporate Update (2026)Corcept Therapeutics · 29 Jul 2026 · Company press release
- Corcept Therapeutics Announces Third Quarter Financial Results and Provides Corporate Update (2026)Corcept Therapeutics · 3 Nov 2026 · Company press release
Can I join?No trial recruiting; Phase 3 not yet openExplanation and sources
The DAZALS registry entry is listed as active but not recruiting, so new people cannot join. The Phase 3 trial is not yet registered or enrolling. We found no expanded access programme.
- DAZALS (Phase 2, with dose-titration part) (NCT05407324) active not recruiting · Europe, USA, Canada
Sources
- DAZALS trial of dazucorilant in ALS (NCT05407324)ClinicalTrials.gov · Trial registry
- Corcept Therapeutics Announces Third Quarter Financial Results and Provides Corporate Update (2026)Corcept Therapeutics · 3 Nov 2026 · Company press release
Signal: Active
Signal measures how often, and how reliably, Corcept Therapeutics tells the public about this drug. It says nothing about whether the drug works. A quiet company isn't necessarily a bad sign, but regular, on-time updates help patients plan.
| Last company update | 3 Nov 2026 (2 days ago) | 40 / 40 |
|---|---|---|
| Company updates in the last 12 months | 6 | 35 / 35 |
| Promises kept | 1 of 3 on time | 8 / 25 |
| Signal score | 83 / 100 · Active | |
Announced milestones
- Delivered on time One-year overall survival results from DAZALS (promised for Q2 2025, delivered 5 Jun 2025)
- Dropped Start Phase 3 trial by mid-2026 (promised for First half of 2026)
- Dropped Start Phase 3 trial later in 2026 (promised for 2026)
- Not due yet Start Phase 3 trial early in 2027 (promised for First half of 2027)
70 or more is Active, 45 or more is Steady, 20 or more is Quiet, below 20 is Silent. Full method.
Timeline
12 events, newest first. Company updates are marked; independent news and regulator decisions are shown too.
2026
Phase 3 planned for next year
In its third-quarter 2026 update, Corcept said the pivotal Phase 3 trial in ALS is planned to begin next year, without giving a more exact date.
Two-year survival poster at NEALS 2026
Corcept presented the two-year survival results from DAZALS as a poster at the NEALS annual meeting.
Phase 3 start moved to early 2027
In its second-quarter 2026 update, Corcept said the pivotal Phase 3 trial would start early next year, after the dose-titration study informs its design.
Two-year survival results released
Corcept reported an 87% lower risk of death at two years for people on 300 mg compared with placebo patients who never switched to the drug. This is an exploratory comparison with only 18 placebo-only patients.
Phase 3 start moved to later in 2026
In its first-quarter 2026 update, Corcept said the Phase 3 trial would start later in 2026 rather than by mid-year.
Dose-titration study under way; Phase 3 still aimed for mid-2026
Corcept said it had started a small study of slowly increasing the dose to reduce stomach side effects, and still aimed to start Phase 3 by the middle of 2026.
2025
Phase 3 planned to start by mid-2026
In its third-quarter 2025 update, Corcept said it planned to start a Phase 3 trial in ALS by the middle of 2026.
Corcept working with regulators on next steps in ALS
In its second-quarter 2025 update, Corcept said it was working with regulators to plan the next stage of development for dazucorilant in ALS.
One-year survival results presented at ENCALS
Corcept presented an exploratory analysis at the ENCALS meeting showing a lower risk of death at one year for people on 300 mg compared with placebo patients who never switched to the drug.
Corcept expects one-year survival data in the second quarter
In its full-year 2024 update, Corcept said one-year survival results from DAZALS were expected in the second quarter of 2025.
2024
DAZALS Phase 2 misses its main goal, but fewer deaths on 300 mg
Corcept said dazucorilant did not slow the loss of daily function (ALSFRS-R) over 24 weeks. No one on the 300 mg dose died during that time, compared with 5 people on placebo.
Reuters reports the ALS trial failure
Reuters reported that Corcept's ALS drug failed its mid-stage trial.
All sources for this page
- Corcept Announces Results From Phase 2 Study of Dazucorilant in Patients With Amyotrophic Lateral Sclerosis (ALS)Corcept Therapeutics · 11 Dec 2024 · Company press release
- Corcept Therapeutics' ALS drug fails in mid-stage trialReuters · 11 Dec 2024 · News
- Corcept Therapeutics Announces Fourth Quarter and Full-Year 2024 Audited Financial Results and Provides Corporate UpdateCorcept Therapeutics · 26 Feb 2025 · Company press release
- Corcept Presents Results from Phase 2 Study of Dazucorilant in Patients with ALS at ENCALS 2025 Annual MeetingCorcept Therapeutics · 5 Jun 2025 · Company press release
- DAZALS results poster, ENCALS 2025Corcept Therapeutics · 5 Jun 2025 · Conference presentation
- DAZALS: A Phase 2, Randomized, Double Blind, Placebo-Controlled Trial of Dazucorilant in ALS (ENCALS 2025 presentation)Corcept Therapeutics · Conference presentation
- Corcept's dazucorilant shows large survival signal in ALS despite Phase II primary endpoint missAllSci · News
- Corcept Therapeutics Announces Second Quarter Financial Results and Provides Corporate Update (2025)Corcept Therapeutics · 31 Jul 2025 · Company press release
- Corcept Therapeutics Announces Third Quarter Financial Results, Oncology Development Programs and Provides Corporate Update (2025)Corcept Therapeutics · 4 Nov 2025 · Company press release
- Corcept Therapeutics Announces Fourth Quarter and Full-Year 2025 Audited Financial Results, Provides Corporate UpdateCorcept Therapeutics · 24 Feb 2026 · Company press release
- Corcept Phase 2 Study of Dazucorilant Demonstrates Two-Year Overall Survival Benefit in Patients with Amyotrophic Lateral SclerosisCorcept Therapeutics · 30 Apr 2026 · Company press release
- Corcept Therapeutics Announces First Quarter Financial Results and Provides Corporate Update (2026)Corcept Therapeutics (via StockTitan) · 30 Apr 2026 · Company press release
- Corcept ties ALS drug to improved 2-year survival as Phase 3 start date nearsBioSpace · News
- Corcept Therapeutics Announces Second Quarter Financial Results and Provides Corporate Update (2026)Corcept Therapeutics · 29 Jul 2026 · Company press release
- 2-Year Overall Survival Results From DAZALS (NEALS 2026 poster)Corcept Therapeutics · 29 Oct 2026 · Conference presentation
- Corcept Therapeutics Announces Third Quarter Financial Results and Provides Corporate Update (2026)Corcept Therapeutics · 3 Nov 2026 · Company press release
- Corcept Therapeutics Form 10-Q for the quarter ended September 30, 2026U.S. Securities and Exchange Commission · Regulator
- DAZALS trial of dazucorilant in ALS (NCT05407324)ClinicalTrials.gov · Trial registry